Microbial Out of Limits Investigator at Rose International
Marion, NC 28752
About the Job
***Only qualified Microbial Out-of-Limits Investigator candidates located near Marion, NC area to be considered due to the position requiring an onsite presence***
The Microbial Out-of-Limits Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence.
Education & Experience:
• Bachelor’s or master''s degree in science in Microbiology or related field with 2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry
• Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality
Qualifications:
• Strong communication and project management skills
• Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
• Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
• Must have strong technical writing skills and able to put complex thoughts and issues into writing in such a manner that can be understood by the reader
• Must be able to interact with, and influence others at various levels in multiple departments
• Must have knowledge of FDA quality systems regulations
• Must have working knowledge of TrackWise system
Duties:
• Determines scope, product impact, root cause, corrective and/or preventive actions of microbial excursions including surfaces, viable air, non-viable air, water, bioburden and endotoxin testing results
• Expeditiously identifies potential root causes for excursions and immediate mitigation actions
• Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
• Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
• Closes investigations in a timely manner to meet business and compliance needs
• Works with minimal supervision to drive investigations to closure
• Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
• Manages investigation and CAPA documentation in TrackWise in compliance with practices and procedures
• Understands and implements procedures that support implementation of CAPAs
• Presents and defends investigations during regulatory inspections, as required
**Only those lawfully authorized to work in the designated country associated with the position will be considered.**
**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here .Should you have any questions / concerns, please contact our HR Department via our secure website .
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender(expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law.Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
